Medpace PhD Virtual Info Session - February 11th

				Overview:

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Responsibilities:

Associate Clinical Trial Manager - Clinical Trial Management 

* Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager;
* Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy;
* Compile and maintain project-specific status reports within the clinical trial management system;
* Interact with the internal project team, Sponsor, study sites, and third-party vendors;
* Provide oversight and quality control of our internal regulatory filing system;
* Provide oversight and management of study supplies;
* Create and maintain project timelines; and
* Coordinate project meetings and produce quality minutes.

Clinical Research Associate - Clinical Monitoring 

* Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
* Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
* Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating  protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
* On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
* Verification that the investigator is enrolling only eligible subjects;
* Regulatory document review;
* Medical device and/or investigational product/drug accountability and inventory;
* Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
* Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Regulatory Submissions Coordinator

* Communicate with research sites (doctor's offices, universities, hospitals, etc.) to collect all essential documents required before the site begins to screen patients to participate in the clinical trial;
* Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF);
* Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB);
* Maintain timelines for study start-up through both internal and external collaboration; and
* Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Clinical Data Coordinator

* Validate entry database designs
* Report metrics and data trends on projects
* Identify data conflicts and issues on projects
* Work with personnel from global research sites to resolve data conflicts
* Reconcile data from multiple sources
* Create and update study documentation on projects
* Participate as part of a team on various projects

Qualifications:

* PhD in Life Sciences;
* Fluency in English with solid presentation skills;
* Ability to work in a fast-paced dynamic industry within an international team; 
* Prior experience within the CRO or pharmaceutical industry not required but will be advantageous; and
* Excellent computer (word-processing, databases, Excel, Windows), organizational, and communication skills.
* Willingness to relocate to our Cincinnati, OH or Dallas, TX office.
			

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